Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 382a57d1-85bf-480f-9967-f85da2904410
Routes
ORAL TOPICAL
Published
Effective Date 2025-05-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Mineral Oil (100 mg)
Inactive Ingredients
Tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-02-28
Description

Mineral Oil 100%

Purpose

Lubricant laxative

Medication Information

Purpose

Lubricant laxative

Description

Mineral Oil 100%

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 6 to 8 hours
Directions
  • do not take with meals
  • take only at bedtime
  • may be taken as a single daily dose or in divided doses
  • adults and children 12 years of age and over
    • 1 to 3 tablespoons (15 to 45 mL)
    • maximum 3 tablespoons (45 mL) in 24 hours
  • children under 12 years, consult a doctor 
Do Not Use
  • in children under 6 years of age, pregnant wormen, bedridden patients or persons with difficulty swallowing
  • if you are presently taking a stool softener laxative
  • for longer than 1 week unless directed by a doctor
Package Label

Mineral Oil Lubricant Laxative front label
Mineral Oil Lubricant Laxative back label
 

Active Ingredient

Mineral Oil 100%

Other Information
  • keep tightly closed
  • protect from direct light
Inactive Ingredient

Vitamin E as stabilizer

Principal Display Panel

Mineral oil

LUBRICANT LAXATIVE

  • odorless
  • tasteless
  • colorless

FL OZ (mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY PUBLIX SUPER MARKETS, INC.,

3300 PUBLIX CORPORATE PARKWAY

LAKELAND, FL 33811

publix.com

When Using This Product
  • do not take with meals
  • take only at bedtime
Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control center (1-800-222-1222) right away.

If Pregnant Or Breast Feeding,

ask a health professional before use. As with any drug, if you are nursing a baby, seek the advice of a health professional before using this product.

Ask A Doctor Before Use If You Have
  • abdominal pain, nausea or vomiting
  • noticed a sudden change in bowel habits that persists over a period of 2 weeks
Stop Use and Ask A Doctor If You Have

rectal bleeding or failure to have a bowel movement after use. These could be signs of a serious condition.

Structured Label Content

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 6 to 8 hours
Purpose

Lubricant laxative

Directions
  • do not take with meals
  • take only at bedtime
  • may be taken as a single daily dose or in divided doses
  • adults and children 12 years of age and over
    • 1 to 3 tablespoons (15 to 45 mL)
    • maximum 3 tablespoons (45 mL) in 24 hours
  • children under 12 years, consult a doctor 
Do Not Use (Do not use)
  • in children under 6 years of age, pregnant wormen, bedridden patients or persons with difficulty swallowing
  • if you are presently taking a stool softener laxative
  • for longer than 1 week unless directed by a doctor
Package Label

Mineral Oil Lubricant Laxative front label
Mineral Oil Lubricant Laxative back label
 

Active Ingredient

Mineral Oil 100%

Other Information
  • keep tightly closed
  • protect from direct light
Inactive Ingredient

Vitamin E as stabilizer

Principal Display Panel

Mineral oil

LUBRICANT LAXATIVE

  • odorless
  • tasteless
  • colorless

FL OZ (mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY PUBLIX SUPER MARKETS, INC.,

3300 PUBLIX CORPORATE PARKWAY

LAKELAND, FL 33811

publix.com

When Using This Product (When using this product)
  • do not take with meals
  • take only at bedtime
Keep Out of Reach of Children (Keep out of reach of children)

In case of overdose, get medical help or contact a Poison Control center (1-800-222-1222) right away.

If Pregnant Or Breast Feeding, (If pregnant or breast feeding,)

ask a health professional before use. As with any drug, if you are nursing a baby, seek the advice of a health professional before using this product.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • abdominal pain, nausea or vomiting
  • noticed a sudden change in bowel habits that persists over a period of 2 weeks
Stop Use and Ask A Doctor If You Have (Stop use and ask a doctor if you have)

rectal bleeding or failure to have a bowel movement after use. These could be signs of a serious condition.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:12.308531 · Updated: 2026-03-14T23:08:52.632356